MAUDE Adverse Event Report: COMFORT; UNO COMFORT 110/17 SC1 MINI

Model Number	MMT-377A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient faced infusion set tubing detachment event on (b)(6) 2025.The insertion site was the left abdomen.The tubing got detached from connector.Infusion set was used for atleast two days.Blood glucose level was high at the time of the event.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united states.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted expiration date under d4.Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: electronic quality management system (eqms) search: a query was run in the eqms on 20/apr/2026 against "lot number" "6012518" and similar malfunction codes: leak between tubing and site connector detachment / significant wetness, leakage from connection between the tubing connector and the infusion set (cannula part/base piece), tubing detached from tubing-tubing connector.The review confirmed that lot 6012518 and the identified failure mode are not associated with any nonconforming reports (ncr)s or corrective and preventive action (capa)s of the same or similar nature.Similar complaints search: a query was run in the eqms on 20/apr/2026 against "lot number" criteria equal "6012518" and similar malfunction codes: leak between tubing and site connector detachment / significant wetness, leakage from connection between the tubing connector and the infusion set (cannula part/base piece), tubing detached from tubing-tubing connector.The count of complaints is 1.The complaints numbers are 2457346.Device history record (dhr) review: the lot 6012518 was manufactured according to work instruction (wi) version 21 and manufactured in the machine multivac 14, on 01/apr/2025 with a total of (b)(6) units.Glue-tubing lot: the lot 5b04786 was manufactured according to wi version 15 and manufactured in the machine lc01, on 24/feb/2025 with a total of (b)(6) units.The lot 5c04053 was manufactured according to wi version 17 and manufactured in the machine lc01, on 26/mar/2025 with a total of (b)(6) units.The device history record (dhr) was reviewed in accordance with applicable procedures.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no maintenance events were recorded that relate to the complaint code.Conclusion: dhr review identified minor findings.They were managed according to procedure and did not impact compliance; no issues noted.Visual evidence review: no photo was provided to support visual confirmation of the reported issue.Conclusion: unable to perform visual verification; assessment based on available documentation only.Capa determination assessment - conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per wi (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Conclusion summary of complaint investigation: as a result of the following a comprehensive review was conducted, including eqms queries, similar complaint searches, device history record review, visual evidence assessment, and capa determination.No ncrs or capas of the same or similar nature were found for lot 6012518 and related malfunction codes for leak issues.One complaint was identified for this lot, but no trend or systemic issue was detected.The manufacturing records confirmed that the lot was produced in compliance with all requirements, with no deviations or maintenance events noted.No photo evidence was provided, so the assessment was based on documentation only.Based on these results, no manufacturing or quality issues were identified, and no further investigation is required.The record will be closed and monitored through routine tracking and trending.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: COMFORT
• Common Device Name: UNO COMFORT 110/17 SC1 MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 23971364
• Report Number: 3003442380-2025-17796
• Device Sequence Number: 15710831
• Product Code: FPA
• UDI-Device Identifier: 05705244019522
• UDI-Public: 05705244019522
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-377A
• Device Lot Number: 6012518
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown